fungoid tincture

Product NDC: 0884-0293
11-digit product format: 008840293
Labeler code: 0884
Product ID: 0884-0293_24ae5b13-853c-1311-e063-6394a90aa6ac
Type: HUMAN OTC DRUG
Nonproprietary name: miconazole nitrate
Dosage form: TINCTURE
Route: TOPICAL
Labeler: Pedinol Pharmacal, Inc.
Application: M014
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2012-04-11
Substance: MICONAZOLE NITRATE
Active strength: 20 mg/mL
Pharmacologic classes: Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

Finished product: Yes
Brand name base: fungoid tincture
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MICONAZOLE NITRATE	20 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
VW4H1CYW1K	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
998525	Internal RxNorm lookup
998526	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
250d0a66-01d1-4aba-8f24-4cb4ca529fda	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
48747306-602a-42cc-957b-5b0c69158eee	Product name	1	20180604
3a55f4fb-5aec-4c88-0ff7-4d608ad4866a	Product name	1	20140508
5b9a7965-36d2-8412-dcaf-f76a65411611	Product name	1	20140508
9869efd7-d6dd-0665-5b67-53adbe6ef15e	Product name	1	20140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0884-0293-01	fungoid tincture	29.57 mL in 1 BOTTLE, WITH APPLICATOR	TINCTURE	29.57		8
0884-0293-01	fungoid tincture	1 in 1 CARTON	TINCTURE	1		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0884-0293-01	ML - Milliliter	0884-0293	c8854e7a-8786-48ac-91e1-b9ab9ded7731	1	2014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Miconazole Nitrate	ACTIVE INGREDIENT	VW4H1CYW1K	FUNGOID TINCTURE (MICONAZOLE NITRATE) TINCTURE [PEDINOL PHARMACAL, INC.]	1
Miconazole	ACTIVE MOIETY	7NNO0D7S5M	FUNGOID TINCTURE (MICONAZOLE NITRATE) TINCTURE [PEDINOL PHARMACAL, INC.]	1
Acetic Acid	INACTIVE INGREDIENT	Q40Q9N063P	FUNGOID TINCTURE (MICONAZOLE NITRATE) TINCTURE [PEDINOL PHARMACAL, INC.]	1
Benzyl Alcohol	INACTIVE INGREDIENT	LKG8494WBH	FUNGOID TINCTURE (MICONAZOLE NITRATE) TINCTURE [PEDINOL PHARMACAL, INC.]	1
Isopropyl Alcohol	INACTIVE INGREDIENT	ND2M416302	FUNGOID TINCTURE (MICONAZOLE NITRATE) TINCTURE [PEDINOL PHARMACAL, INC.]	1
Laureth-4	INACTIVE INGREDIENT	6HQ855798J	FUNGOID TINCTURE (MICONAZOLE NITRATE) TINCTURE [PEDINOL PHARMACAL, INC.]	1
Water	INACTIVE INGREDIENT	059QF0KO0R	FUNGOID TINCTURE (MICONAZOLE NITRATE) TINCTURE [PEDINOL PHARMACAL, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0884-0293	FUNGOID TINCTURE (MICONAZOLE NITRATE) TINCTURE [PEDINOL PHARMACAL, INC.]	8	Current NDC, Legacy NDC, 2 package rows	20241019_250d0a66-01d1-4aba-8f24-4cb4ca529fda.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 7 · 136 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
EarBalance Ear Pain Drops	LIDOCAINE HYDROCHLORIDE OTIC SOLUTION	Marie's Original Formulas LLC	54dc3642-0b7a-07d8-e063-6294a90ad556	2026-07-22	Warnings	Exact identifier application number: M014
EarBalance Ear Pain Drops	LIDOCAINE HYDROCHLORIDE OTIC SOLUTION	Marie's Original Formulas LLC	55057e1b-b11e-51b9-e063-6394a90a9fca	2026-07-22	Warnings	Exact identifier application number: M014
Macks Dry n Clear	EAR DRYING AID	McKeon Products Inc	1ea1da54-2412-c25c-e063-6294a90aa264	2026-06-26	Warnings	Exact identifier application number: M014
Equate Swimmers Instant Ear Dry	EQUATE SWIMMERS INSTANT EAR DRY	Walmart Stores, Inc	76b58a7a-48cf-866c-e053-2a91aa0a7e63	2026-06-26	Warnings	Exact identifier application number: M014
Quality Choice Earwax Removal Drops Earwax Removal Aid	CARBAMIDE PEROXIDE	Chain Drug Marketing Association, Inc.	c68b40d9-c1d4-4425-8063-50c00299e718	2026-06-10	Warnings	Exact identifier application number: M014
Quality Choice Earwax Removal Kit Earwax Removal Aid and Bulb	CARBAMIDE PEROXIDE	Chain Drug Marketing Association, Inc.	b2a641da-e070-4223-b836-5ca9ffb89f3f	2026-06-10	Warnings	Exact identifier application number: M014
Freskaro Ear Drops for Swimmers	FRESKARO EAR DROPS FOR SWIMMERS	Pharma Nobis, LLC	4f724d85-cd38-41da-e063-6394a90a9fd7	2026-06-03	Warnings	Exact identifier application number: M014
Audiologists Choice Earwax Removal System	CARBAMIDE PEROXIDE	Oaktree Products Inc.	c9ad507b-341c-474f-aaa2-3c3a97a30dd8	2026-05-29	Warnings	Exact identifier application number: M014
CVS Health Earwax Removal Kit	CARBAMIDE PEROXIDE	CVS Pharmacy, Inc.	f842534c-46dd-42c7-8386-9a03ce16da86	2026-05-29	Warnings	Exact identifier application number: M014
Lucid Hearing Earwax Removal Kit and Bulb	CARBAMIDE PEROXIDE	Hearing Lab Technology LLC	5e09f566-397f-44d6-8ba2-90987765c737	2026-05-29	Warnings	Exact identifier application number: M014
Good Neighbor Pharmacy Earwax Removal Drops	CARBAMIDE PEROXIDE	Amerisource Bergen	89eac1b0-c700-45b5-8478-da53ace72e16	2026-05-29	Warnings	Exact identifier application number: M014
Good Neighbor Pharmacy Earwax Removal	CARBAMIDE PEROXIDE	Amerisource Bergen	d503b10f-85cd-4bb8-9dec-82d651d525fa	2026-05-29	Warnings	Exact identifier application number: M014
Meijer Earwax Removal Kit	CARBAMIDE PEROXIDE	Meijer Distribution Inc.	a5f7bd55-55c3-4b0e-a16c-33bbea40536a	2026-05-29	Warnings	Exact identifier application number: M014
Quality Choice Earwax Removal Drops	CARBAMIDE PEROXIDE	Chain Drug Marketing Association, Inc.	d8fd8102-114f-415d-9083-f98a63f9d1b3	2026-05-29	Warnings	Exact identifier application number: M014
Menthol Pain Relieving Gel	PAIN RELIEVING GEL	NeilMed Pharmaceuticals Inc	513a206c-bbf6-3e51-e063-6294a90adf7a	2026-05-07	Warnings	Exact identifier application number: M014
ear drops	CARBAMIDE PEROXIDE 6.5%	Bionpharma Inc.	e8bcf92c-ad32-49d5-e053-2995a90ae0c6	2026-04-27	Warnings	Exact identifier application number: M014
Freskaro Earwax Removal Aid	CARBAMIDE PEROXIDE 6.50% KIT	Pharma Nobis, LLC	4f5967ee-bc05-341c-e063-6394a90a35c6	2026-04-15	Warnings	Exact identifier application number: M014
GoodSense Ear Wax Removal Kit	CARBAMIDE PEROXIDE	Preferred Pharmaceuticals Inc.	9a4198d2-cbea-466a-a252-d5c63d9ea0c1	2026-04-09	Warnings	Exact identifier application number: M014
Good Neighbor Pharmacy Earwax Removal Drops	CARBAMIDE PEROXIDE	Preferred Pharmaceuticals Inc.	52f733a7-1301-4078-9267-5ce95b006ccc	2026-04-09	Warnings	Exact identifier application number: M014
Walgreens Swimmers Ear	ISOPROPYL ALCOHOL	Walgreens Co	3fb65a5c-c47f-ef2b-e063-6394a90af21a	2026-04-01	Warnings	Exact identifier application number: M014

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
VW4H1CYW1K	MICONAZOLE NITRATE	22832-87-7	MICONAZOLE NITRATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
998526	Fungoid 2 % tincture treatment kit	PSN	250d0a66-01d1-4aba-8f24-4cb4ca529fda	8
998525	miconazole nitrate 2 % Topical Solution	PSN	250d0a66-01d1-4aba-8f24-4cb4ca529fda	8
998526	miconazole nitrate 20 MG/ML Topical Solution [Fungoid]	SBD	250d0a66-01d1-4aba-8f24-4cb4ca529fda	8
998525	miconazole nitrate 20 MG/ML Topical Solution	SCD	250d0a66-01d1-4aba-8f24-4cb4ca529fda	8
998526	Fungoid 2 % Topical Tincture	SY	250d0a66-01d1-4aba-8f24-4cb4ca529fda	8
998526	Fungoid 20 MG/ML Topical Solution	SY	250d0a66-01d1-4aba-8f24-4cb4ca529fda	8
998525	miconazole nitrate 2 % Topical Solution	SY	250d0a66-01d1-4aba-8f24-4cb4ca529fda	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0884-0293-01	00884029301	1 BOTTLE, WITH APPLICATOR in 1 CARTON (0884-0293-01) / 29.57 mL in 1 BOTTLE, WITH APPLICATOR	2012-04-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
fungoid tincture - Pedinol Pharmacal, Inc. \| EMS Acquisition Corp.	Pedinol Pharmacal, Inc. \| EMS Acquisition Corp.	2024-10-17	HUMAN OTC DRUG LABEL	8
Ketoconazole Cream, 2%	NuCare Pharmaceuticals,Inc.	2021-07-28	HUMAN PRESCRIPTION DRUG LABEL	3